Anti-tampering apparatus and method for drug delivery devices

ABSTRACT

An anti-tampering apparatus and method for drug delivery devices provides for the capture of caps in a manner that restricts repositioning of a captured cap onto a corresponding drug delivery device. The anti-tampering apparatus includes one or more retention members to define a capture region for restrainably capturing a cap. The anti-tampering apparatus further locates an obstruction surface thereof to engage a surface of a drug delivery device and thereby restrict recapping of the device by the captured cap. As such, tampering of a drug delivery device is indicated by the absence of a cap captured within the anti-tampering apparatus.

RELATED APPLICATIONS

This application is a continuation application of U.S. patentapplication Ser. No. 13/045,742 filed Mar. 11, 2011, which claims thebenefit of U.S. Provisional Application No. 61/409,466, filed Nov. 2,2010, entitled “ANTI-TAMPERING APPARATUS AND METHOD FOR DRUG DELIVERYDEVICES”, both of which are hereby incorporated by reference in theirentirety.

FIELD OF THE INVENTION

The present invention relates to drug delivery devices, and moreparticularly, to an anti-tampering apparatus and method for use withdrug delivery devices. The invention is particularly apt for use withdrug delivery devices, such as syringes and oral dispensers, afterfilling with a liquid medication.

BACKGROUND OF THE INVENTION

Drug delivery devices are commonly used to hold and deliver prescribedquantities of medication to a patient. Exemplary drug delivery devicesinclude, but are not limited to syringes, oral syringes, vials and othercapped containers that function to hold and deliver a prescribed andprecise amount of liquid medication to a patient.

Once filled with a liquid medication and capped, it is important thatthe drug delivery device be provided to a patient care site foradministration to the intended patient with the integrity of thecontents thereof uncompromised. Further, in the event that the drugdelivery device is not used at a patient care site, it may be importantthat the drug delivery device be returned (e.g., to a pharmacy) so thatthe contents thereof may be handled in an appropriate manner. Suchconsiderations are particularly important when certain medical liquids,such as narcotic drugs, are being handled.

In this regard, numerous approaches have been proposed for indicatingwhen a drug delivery device has been tampered with prior to or otherwiseapart from intended patient administration. One approach that has beenproposed for use in conjunction with syringes is a break-away, coloredsleeve that caps a syringe. The colored sleeves may be divided andarranged in a tray prior to being mated with syringes such that a usermay cap the syringe directly by inserting the end of the syringe to becapped into one selected colored sleeve that is in the tray, resultingin the colored cap being securely attached to the end. If the syringe istampered with and the contents are accessed through the capped end, thecolored sleeve will be broken, thereby providing a visual indicator thatthe syringe has been tampered with. In another approach, an open end ofa syringe may be capped with a shell that is constructed such thattampering with the syringe results in the shell being broken-away in amanner that provides a visual indicator that the syringe has beentampered with.

In each of the noted approaches, as well as additional approaches thathave been proposed, visual indications are relied upon to identify theoccurrence of tampering. In such approaches, recapping of a tamperedsyringe is not restricted, only indicated upon visual inspection.

SUMMARY OF THE INVENTION

One objective of the present invention is to provide an improvedanti-tampering apparatus and method that restricts recapping of a drugdelivery device together with the anti-tampering apparatus.

Another objective of the present invention is to provide an improvedanti-tampering apparatus and method that is user-friendly.

Yet another objective of the present invention is to provide an improvedanti-tampering apparatus and method for drug delivery devices that maybe implemented in a cost effective manner.

One or more of the above objectives and additional advantages may berealized by an anti-tampering apparatus and method comprising thepresent invention.

In one embodiment, an anti-tampering apparatus is provided that includesa frame member. The apparatus further includes at least one retentionmember connected to the frame member for non-removable capture of a capdisposed on a port of a corresponding drug delivery device (e.g., asyringe, an oral dispenser, or other like devices filled with a liquidmedication for patient administration). The frame may define an internalor encompassed area having an opening, wherein the retention member(s)may extend into the internal area to define a cap capture region spacedrearward from the opening.

The anti-tampering apparatus may be provided so that a cap capturedwithin the apparatus is restricted from replacement on a correspondingdrug delivery device port after initial removal therefrom. As may beappreciated, the absence of a captured cap on a drug delivery deviceand/or the presence of a cap without the anti-tampering apparatusproperly interconnected thereto provides a user with an immediate andeasily perceptible indication that tampering may have occurred.

In one aspect, the anti-tampering apparatus may include an obstructionsurface for obstructing replacement of a captured cap back onto a portof a corresponding drug delivery device after initial removal therefrom.In one approach, the obstruction surface may be located on the framemember of the anti-tampering apparatus. By way of example, theobstruction surface may be presented on a peripheral edge of acylindrical end portion of the frame member. In other approaches, theobstruction surface may be provided on the cap retention member(s).

In another approach, the anti-tampering apparatus may include at leastone pivot member connected to the frame, wherein the pivot member(s)pivots from a first position to a second position when a cap disposed ona drug delivery device is positioned within the capture region. In turn,the obstruction surface may be provided on the pivot member when thecaptured cap is removed from the drug delivery device.

In one embodiment, the pivot member may comprise a first portion and asecond portion, wherein a cap disposed on a corresponding drug deliverydevice may engage the first portion upon positioning within the captureregion and, in response to such engagement, the second portion may pivotfrom a first position to a second position. In the second position, thesecond portion may be in spring-loaded engagement with a portion of thedrug delivery device. For example, at least one of the pivot member(e.g., the second portion thereof) and the frame may elastically deformwhen the pivot member is moved to the second position (e.g., in responseto engagement with a portion of the drug delivery device). In turn, uponremoval of the captured cap from the drug delivery device, the secondportion may automatically advance inward to present an obstructionsurface.

In various embodiments, a cap disposed on a drug delivery device portmay be forcibly advanced in a first direction past the retentionmember(s) into the capture region. In this regard, at least a portion ofthe retention member(s) and/or frame and/or cap may flex, or elasticallydeform, during advancement and cap capture. Upon cap capture, thecaptured cap may be restrained from movement in an opposite seconddirection by the retention member(s).

By way of example, the retention member(s) may comprise a detent(s)projecting inward (e.g., into the internal area) from a wall of theframe member. In some implementations, the detent(s) may be of a barbedconfiguration having a tapered first surface extending inward from thewall and away from the opening, and a second surface, or ledge, forrestrainably engaging a cap captured by the anti-tampering apparatus. Invarious arrangements, a plurality of retention members (e.g., three ormore detents or segments or sets of detents) may be spaced (e.g., atequidistances relative to each other and from the opening) about aninternal wall of the frame.

In contemplated embodiments, the anti-tampering apparatus may beprovided so that a length of the capture region is greater than a lengthof the cap captured by the anti-tampering apparatus. Further, thecapture region may be sized to permit a captured cap to move rearwardlywithin the capture region.

To facilitate cap capture in various embodiments, the retentionmember(s) may be provided to define a minimum cross-dimension within theinternal area that is less than a maximum cross-dimension of the cap. Insome implementations, the retention member(s) may be provided to definea reduced opening (e.g., a segmented circular opening) within theinternal area having a diameter that is less than a maximum diameter ofa cap (e.g., a cap having a circular periphery at its maximumcross-dimension). By way of example, a plurality of retention member(s)may extend into the internal area from a wall of the frame to defineminimum cross-dimension and/or a reduced opening having a diameter thatis less than a maximum cross-dimension and/or maximum diameter of a cap,respectively.

In some embodiments, the anti-tampering apparatus may be provided withan end wall at an opposite end from the opening. By way of example, theend wall may be provided at a rearward end of the capture region.

As may be appreciated, an inventive method is also provided. In oneembodiment, a method is provided for handling a drug delivery devicehaving a port, and a corresponding cap positionable on the port, suchmethod including the steps of capturing a cap disposed on a port of adrug delivery device within an anti-tampering apparatus, and removingthe cap from the port of said drug delivery device, wherein theanti-tampering apparatus maintains capture of the cap. The embodimentmay further include the step of restricting repositioning of thecaptured cap onto the port of the corresponding drug delivery device.

In some embodiments, the capturing step may include advancing at least aportion of the cap forcibly passed at least one retention member(s)provided on the anti-tampering apparatus, wherein the cap isrestrainably disposed within a captured region of the anti-tamperingapparatus. In conjunction with such advancement and cap capture, themethod may further include resiliently flexing at least a portion of atleast one of the cap and the anti-tampering apparatus. By way ofexample, at least a portion of one or a plurality of retention member(s)and/or a portion of an interconnected frame of the anti-tamperingapparatus may flex in conjunction with forcible advancement of a capinto the captured region relative thereto. Alternatively and/oradditionally, a portion of the cap (e.g., sidewall portions thereof) mayflex in conjunction with forcible advancement of the cap relative to theanti-tampering apparatus.

In relation to the restrictive step of the method embodiment, at leastone obstruction surface may be provided on the anti-tampering apparatus.The obstruction surface may be located to engage a surface of the drugdelivery device and thereby obstruct repositioning of the cap on thepost of the drug delivery device after removal of the cap therefrom. Invarious embodiments, the obstruction surface may be provided by a frameof the anti-tampering apparatus. In other embodiments, the obstructionsurface may be provided on one or members interconnected to a frame ofthe anti-tampering apparatus. In some implementations, the obstructivesurface(s) may be located in an initial position prior to the capturingstep and automatically located in an obstruction position different fromthe initial position after the removing step.

In this regard, the method may include first moving an obstructionsurface(s) from an initial position to another position in response tothe capturing step, and second moving the obstruction surface(s) fromthe another position to the obstruction position in response to theremoving step. In one approach, the obstruction surface(s) may belocated on a pivot member(s) interconnected to a frame of theanti-tampering apparatus. In turn, the method may include pivoting theone pivot member(s) relative to the frame to at least partiallyreposition the obstruction surface(s) from the initial position to theobstruction position in response to the capturing step. In someembodiments, the pivot member(s) may engage the drug delivery deviceupon cap capture and at least a port of the pivot member(s) may and/orthe frame may be provided to elastically deform prior to removal of thecaptured cap from the drug delivery device. In turn, upon such removalthe pivot member(s) may move inward to present the obstructionsurface(s).

In certain implementations, a method embodiment may include theadditional step of filling the drug delivery device with a predeterminedamount of liquid medication prior to the capturing, removing andrestricting steps. By way of example, the filling step may be completedat a medical liquid dispensary (e.g., a pharmacy) of a medical carefacility. As may be appreciated, drug delivery devices may be filled atsuch locations on a patient and/or drug specific basis, wherein afterfilling the drug delivery devices may be transported to specific patientcare locations at the facility for administration to a given patient bymedical personnel.

The method embodiment may further include the step of positioning thecap on the port of the drug delivery device after filling and prior tothe capturing, removing and restricting steps. In some implementations,one or more of the filling, positioning and capturing steps may becompleted in an automated manner. By way of example, each of thefilling, positioning and capturing steps may be automated. In oneapproach, one or more of such steps may be completed utilizing methodsand apparatus taught in U.S. Pat. Nos. 6,915,823; 6,991,002; 7,017,622;7,017,623; 7,117,902; 7,814,731; and U.S. Patent Application PublicationNos. 2007/0125442; 2008/0169043; 2008/0169044; 2008/0169045; and2009/0154764, hereby incorporated by reference their entirety.

In one embodiment, a drug delivery device and corresponding cap may bepackaged in the same or separate enclosures. Further, a correspondinganti-tampering apparatus may be packaged in the same or a separateenclosure. In this regard, the drug delivery device and a plurality oflike drug delivery devices may be packaged in a common enclosure.Similarly, the cap and a plurality of like caps may be packaged in acommon enclosure, and the anti-tampering apparatus and a plurality oflike anti-tampering apparatus may be packaged in a common enclosure. Insome implementations, the plurality of drug delivery devices and/orcorresponding caps and/or corresponding anti-tampering apparatus may bepackaged in a common enclosure.

The above-noted packaging may be completed at a first location. By wayof example, the first location may correspond with a production orassembly facility for the drug delivery device(s) and correspondingcap(s). In conjunction with such packaging, the drug delivery device(s)and cap(s) may be sterilized at the first location (e.g., prior to orafter packaging).

The method embodiment may include transporting the above-notedenclosure(s) from the first location to a second location, remote fromthe first location. By way of primary example, the second location maybe a medical dispensary for a medical care facility. In particular, thesecond location may correspond with a pharmacy for a hospital or otherpatient care facility.

In turn, the method embodiment may include unpackaging the drug deliverydevice(s) and cap(s) at the second location. Then, after unpackaging,the method may provide for completing the filling, positioning (e.g.,capping), capturing, removing and restricting steps at the secondlocation. For example, the filling and positioning steps may becompleted in a clean and sterile environment, and may be completedmanually or in an automated fashion. Similarly, the capturing step maybe completed in a sterile or otherwise clean environment either manuallyor in an automated manner.

In conjunction with such implementations, the method embodiment mayfurther include the step of providing an anti-tampering apparatusseparate and/or with a plurality of like anti-tampering apparatus to thesecond location, separate from the packaged enclosure(s) of drugdelivery devices and caps. The anti-tampering apparatus may be packagedat the same first location as the drug delivery devices and caps, or ata different site, and transported to the second location. In thisregard, production, assembly and/or packaging of the anti-tamperingapparatus may be completed utilizing the same or different proceduresthan those implemented in relation to the drug delivery device(s) andcap(s).

Numerous additional features and advantages of the present inventionwill become apparent to those skilled in the art upon consideration ofthe embodiment descriptions provided hereinbelow.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates one embodiment of an anti-tampering apparatusprovided for use with a syringe and corresponding cap.

FIG. 2 illustrates the embodiment of FIG. 1 with the cap positioned onthe corresponding syringe.

FIGS. 3A and 3B illustrate the embodiment of FIG. 1 with the cappositioned on the syringe captured by the anti-tampering apparatus.

FIGS. 4A and 4B illustrate the embodiment of FIG. 1 with the capturedcap removed from the syringe.

FIG. 5 is a cross-sectional view of the embodiment of FIG. 1, whereinrecapping of the syringe is obstructed by the anti-tampering apparatus.

FIG. 6 illustrates another embodiment of an anti-tampering apparatusprovided for use with an oral syringe, or dispenser, and correspondingcap.

FIG. 7 illustrates the embodiment of FIG. 6 with the cap positioned onthe corresponding oral dispenser.

FIG. 8 illustrates the embodiment of FIG. 6 with the cap positioned onthe corresponding oral dispenser captured by the anti-tamperingapparatus.

FIG. 9 illustrates the embodiment of FIG. 6 with the captured capremoved from the corresponding oral dispenser.

FIG. 10 is a cross-sectional view of the embodiment of FIG. 6, whereinrecapping of the oral dispenser is obstructed by the anti-tamperingapparatus.

FIG. 11 illustrates an additional embodiment of an anti-tamperingapparatus provided for use with a syringe and corresponding cap.

FIG. 12 illustrates the embodiment of FIG. 11 with the cap on thecorresponding syringe.

FIG. 13A is a cross-sectional view of the embodiment of FIG. 11 with thecap positioned on the syringe being inserted into the anti-tamperingapparatus.

FIG. 13B illustrates the embodiment of FIG. 11 with the cap positionedon the syringe capture by the anti-tampering apparatus.

FIG. 14 is a cross-sectional view of the embodiment of FIG. 11 with thecaptured cap being removed from the corresponding syringe.

FIG. 15 is across-sectional view of the embodiment of FIG. 11, whereinrecapping of the syringe is obstructed by the anti-tampering apparatus.

DETAILED DESCRIPTION

FIGS. 1-6 correspond with one embodiment of an anti-tampering apparatus1. The anti-tampering apparatus 1 is provided for use with a drugdelivery device comprising a syringe 50 (e.g., a luer lock syringe) anda slip-on cap 52 intended for positioning on port 54 of syringe 50. Moreparticularly, the anti-tampering apparatus 1 is provided to restrainablyretain, or capture, cap 52. In one application, the syringe 50 may befilled with a drug in a liquid form prior to cap 52 capture byanti-tampering apparatus 1.

The anti-tampering apparatus 1 may comprise a frame member 10.Optionally, and as shown, frame member 10 may be at least partiallytransparent. The anti-tampering apparatus 1 may further include one ormore retention member(s) 20 connected to the frame member 10 anddisposed to capture cap 52. By way of example, the retention member(s)20 may be configured as a detent(s) projecting inwardly from a sidewall12 of the frame member 10. In the illustrated embodiment three (3)segments of detent members may be spaced about the sidewall 12 (e.g., atequal distances therebetween).

The frame member 10 and retention member(s) 20 may be integrally definedin a unitary anti-tampering apparatus embodiment. For example,anti-tampering apparatus 1 may be injection-molded (e.g., utilizing acollapsible mold) from a polymer-based material. In some embodiments,the anti-tampering apparatus may comprise a polypropylene material or astiffer polyethylene or polystyrene material.

In the illustrated embodiment, the frame member 10 is configured as acap, with cylindrical sidewalls 12 and an end wall 13. In otherembodiments, the frame member 10 may assume other configurations.

FIG. 1 illustrates the syringe 50 prior to capping of port 54 by cap 52,and prior to capture of cap 52 by anti-tampering apparatus 1. Suchcapping and capture steps may be sequentially completed, as reflected byFIGS. 2 and 3. Further, such steps may be completed manually and/or inan automated manner by relative linear advancement of cap 52 and port 54of syringe 50, and by relative linear advancement of capped syringe 50and anti-tampering apparatus 1. In some applications, such steps may becompleted in a single-stroke, linear movement of syringe 50. Forexample, cap 52 and anti-tampering apparatus 1 may be held in alignedpositions (see, e.g., FIG. 1) by a fixture and syringe may be linearlyadvanced in a first stroke segment to locate cap 52 on port 54. In turn,capped syringe 50 may be linearly advanced in a second stroke segment tocapture the cap 52 of the capped syringe 50 within the anti-tamperingapparatus 1.

As shown in FIG. 1, the frame member 10 may define an encompassed orinternal area 14 having a length L₂. Further, the frame member 10 maycomprise an opening 16 to the encompassed or internal area 14 forreceiving the cap 52 after positioning the cap 52 on the port 54 ofsyringe 50. In the illustrated embodiment, three (3) retention members20 may be spaced at equal distances from the opening 16.

The retention member(s) 20 may define a capture region 17 having alength L₁. In this regard, the retention member(s) 20 may be provided sothat, after placement of cap 52 on port 54 of syringe 50, as shown inFIG. 2, at least a portion of cap 52 may be forcibly advanced past theretention member(s) 20 in a first direction and retainably capturedwithin the capture region 17, as shown in FIGS. 3A and 3B. In thisregard, at least a portion of retention member(s) 20 and/or frame 10and/or cap 52 may resiliently flex, or elastically deform, during capcapture.

As best shown in FIG. 3B, upon capture of at least a portion of cap 52the retention member(s) 20 may be located to restrict movement of thecap 52 in a second direction opposite to the first direction. By way ofexample, retention member(s) 20 may define a minimum cross-dimension W₁within encompassed or internal area 14 that is less than a maximumcross-dimension W₂ of cap 52. In the illustrated embodiment, the maximumcross-dimension W₂ of cap 52 may be defined by outwardly projectingflange 52 a of cap 52.

The retention member(s) 20 may be of a barb-like configuration, whereinthe retention member(s) 20 includes a tapered surface 21 and ledgesurface 22. The retention member(s) 20 may be disposed to restrainablyengage flange 52 a of cap 52 at ledge surface 22 when captured cap 52 ismoved toward opening 16.

In that regard, upon capture of at least a portion of cap 52 in captureregion 17 (e.g., flange 52 a), syringe 50 and/or anti-tamperingapparatus 1 may be moved relative to the other, e.g., syringe 50 may beretracted in the second direction while anchoring anti-tamperingapparatus 1, wherein captured cap 52 may be removed from port 54 ofsyringe 50, as shown in FIGS. 4A and 4B. In conjunction with removal ofcap 52, flange 52 a thereof may engage and be restrainably retainedwithin capture region 17 by retention member(s) 20. As may beappreciated, such cap removal may be completed in conjunction withintended procedures in which the liquid drug may be administered fromsyringe 50 to an intended patient after removal of cap 52.

As shown by FIG. 5, the anti-tampering apparatus may be provided so thatonce cap 52 is captured in capture region 17 of anti-tampering apparatus1, and cap 52 is removed from port 54 of the syringe 50, theanti-tampering apparatus 1 may obstruct any attempt to recap the port 54with the captured cap 52. In this regard, the frame member 10 maycomprise a cylindrical edge surface 18 surrounding opening 16. The edgesurface 18 may be located to obstruct recapping of syringe 50 aftercapture of cap 52 within the capture region 17 and removal of cap 52from port 54 of syringe 50. Specifically, after removal of cap 52, edgesurface 18 may engage a barrel surface 56 of the syringe 50 to obstructrecapping of port 54. Concomitantly, cap 52 may assume a position in arearward, or bottom, portion of the capture region 17, as shown in FIG.5.

In the embodiment shown in FIGS. 1-5, syringe 50 may comprise a barrel(e.g., having volumetric gradations, or indicia, thereupon) and aplunger disposed therein for selective dispensation of predeterminedamounts of a liquid drug (e.g., a predetermined unit dosage amounts).Syringe 50 may be of a type having a port 54 adapted for forcible,slip-on placement of cap 52. In this regard, syringe 50 may be of a typehaving a luer-lock connection arrangement at port 54, as shown in FIGS.1, 2, 3A and 4A. For example, port 54 may include a nozzle 54 aextending through and beyond a surrounding collar 54 b having a threadedinternal sidewall. In turn, cap 52 may include an annular (e.g.,cylindrical) inner collar 52 b and an annular (e.g., cylindrical) outercollar 52 c extending from an end wall 52 d, wherein nozzle 54 a may beforcibly advanced in a slip-on fashion into inner collar 52 b of cap 52,and outer collar 54 b of port 54 may be located in an annular regiondefined between inner collar 54 b and outer collar 52 c of cap 52.

Since positioning of cap 52 upon syringe 50 may entail forcibleadvancement of port 54 relative to cap 52, cap 52 may assume a rearwardposition in capture region 17 upon any attempt to recap port 54 afterremoval of cap 52. In conjunction therewith, any attempt to recap thesyringe 50 may be frustrated by obstructive engagement between edgesurface 18 and barrel surface 56. As such, undesired tampering may beavoided since any unexpected absence of cap 52, as captured byanti-tampering apparatus 1, on port 54 of syringe 50 may provide adefinite indication that tampering has occurred.

FIGS. 6-10 correspond with another embodiment of an anti-tamperingapparatus 101. The anti-tampering apparatus 101 is provided for use witha drug delivery device comprising an oral syringe 150, or dispenser, anda slip-on cap 152 intended for positioning on port 154 of dispenser 150.More particularly, the anti-tampering apparatus 101 is provided torestrainably retain, or capture, cap 152. In one application, thedispenser 150 may be filled with a drug in a liquid form prior to cap152 capture by anti-tampering apparatus 101.

The anti-tampering apparatus 101 may comprise a frame member 110.Optionally, and as shown, frame member 110 may be at least partiallytransparent. The anti-tampering apparatus 101 may further include one ormore retention member(s) 120 connected to the frame member 110 anddisposed to capture cap 152. By way of example, the retention member(s)120 may be configured as a detent(s) projecting inwardly from a sidewall112 of the frame member 110. In the illustrated embodiment three (3)sets of detent members may be spaced about the sidewall 112.

The frame member 110 and retention member(s) 120 may be integrallydefined in a unitary anti-tampering apparatus embodiment. For example,anti-tampering apparatus 101 may be injection-molded (e.g., utilizing acollapsible mold) from a polymer-based material. In some embodiments,the anti-tampering apparatus may comprise a polypropylene material or astiffer polyethylene or polystyrene material.

In the illustrated embodiment, the frame member 110 is configured as acap, with cylindrical sidewalls 112 and an end wall 113. In otherembodiments, the frame member 110 may assume other configurations.

FIG. 6 illustrates the dispenser 150 prior to capping of port 154 by cap152, and prior to capture of cap 152 by anti-tampering apparatus 101.Such further capping and capture steps may be sequentially completed, asreflected by FIGS. 7 and 8. Further, such steps may be completedmanually and/or in an automated manner by relative linear advancement ofcap 152 and port 154 of dispenser 150, and by relative linearadvancement of capped syringe 150 and anti-tampering apparatus 101. Insome applications, such steps may be completed in a single-stroke,linear movement of dispenser 150. For example, cap 152 andanti-tampering apparatus 101 may be held in aligned positions (see,e.g., FIG. 6) by a fixture and syringe may be linearly advanced in afirst stroke segment to locate cap 152 on port 154. In turn, cappeddispenser 150 may be linearly advanced in a second stroke segment tocapture the cap 152 of the capped syringe 150 within the anti-tamperingapparatus 101.

As best shown in FIG. 7, the frame member 110 may define an encompassedor internal area 114 having a length L₃. Further, the frame member 110may comprise an opening 116 to the encompassed or internal area 114 forreceiving the cap 152 after positioning the cap 152 on the port 154 ofdispenser 150.

In turn, the retention member(s) 120 may define a capture region 117having a length L₄. In this regard, the retention member(s) 120 may beprovided so that, after placement of cap 152 on port 154 of dispenser150, as shown in FIG. 7, at least a portion of cap 152 may be forciblyadvanced past the retention member(s) 120 in a first direction andretainably captured within the capture region 117, as shown in FIG. 8.In this regard, at least a portion of retention member(s) 120 and/orframe 110 and/or cap 152 may resiliently flex, or elastically deform,during cap capture. In the latter regard, the retention member(s) 120may be located to restrict movement of the cap 152 in a second directionopposite to the first direction.

After capture of at least a portion of cap 152 in capture region 117,dispenser 150 and/or anti-tampering apparatus 101 may be moved relativeto the other, e.g., dispenser 150 may be retracted in the seconddirection while anchoring anti-tampering apparatus 101, wherein capturedcap 152 may be removed from port 154 of dispenser 150, as shown in FIG.9. In conjunction with removal of cap 152, rounded portion 152 a thereofmay engage and be restrainably retained within capture region 117 byretention member(s) 120. As may be appreciated, such cap removal may becompleted in conjunction with intended procedures in which the liquiddrug may be administered from dispenser 150 to an intended patient afterremoval of cap 152.

As illustrated in FIG. 10, the retention member(s) 120 may be of abarb-like configuration, wherein the retention member(s) 120 includes atapered surface 121 and ledge surface 122. The retention member(s) 120may be disposed to restrainably engage rounded portion 152 a of cap 152at ledge surface 122 when captured cap 152 is moved toward opening 116.By way of example, retention member(s) 120 may define a minimumcross-dimension W₃ of encompassed area 114 that is less than a maximumcross-dimension W₄ of cap 152. In the illustrated embodiment, themaximum cross-dimension W₄ of cap 152 may be defined by a peripheralrounded portion 152 a of cap 152 defining a maximum diameter thereof.

As further shown by FIG. 10, the anti-tampering apparatus 101 may beprovided so that once cap 152 is captured in capture region 117 ofanti-tampering apparatus 101, and cap 152 is removed from port 154 ofthe dispenser 150, the anti-tampering apparatus 101 may obstruct anyattempt to recap the port 154 with the captured cap 152. In this regard,the frame member 110 may comprise a cylindrical edge surface 118 onsidewall 112 surrounding opening 116. The edge surface 118 may belocated to obstruct recapping of dispenser 150 after capture of cap 152within the capture region 117 and removal of cap 152 from port 154 ofdispenser 150. Specifically, after removal of cap 152, edge surface 118may engage a barrel surface 156 of the dispenser 150 to obstructrecapping of port 154. Concomitantly, cap 152 may assume a position in arearward portion of the capture region 117, as shown in FIG. 10.

In the embodiment shown in FIGS. 6-10, oral dispenser 150 may comprise abarrel (e.g., having volumetric gradations, or indicia, thereupon), andplunger disposed therein for selective dispensation of predeterminedamounts of a liquid drug (e.g., a predetermined unit dosage amount).Dispenser 150 may be of a type having a port 154 adapted for forcible,slip-on placement of cap 152. In this regard, dispenser 150 may be of atype utilized for oral dispensation of liquid medication. As shown inFIG. 10, cap 152 may include a shaft-like inner member 152 b surroundedby an annular outer collar 152 c to define an annular regiontherebetween. The inner member 152 b may be sized for mating engagementwithin an end opening of port 154, and port 154 may be received withinthe annular region of cap 152, upon forcible slip-on placement of cap152 on port 154.

Since positioning of cap 152 upon dispenser 150 may entail forcibleadvancement of port 54 relative to cap 152, cap 152 may assume arearward position in capture region 117 upon any attempt to recap port154 after removal of cap 152. In turn, any attempt to recap thedispenser 150 may be frustrated. As such, undesired tampering may beavoided since any unexpected absence of cap 152, as captured byanti-tampering apparatus 101, on port 154 of dispenser 150 would providea definite indication that tampering has occurred.

FIGS. 11-15 correspond with yet another embodiment of an anti-tamperingapparatus 201. The anti-tampering apparatus 201 is provided for use witha drug delivery device comprising a syringe 250 (e.g., a luer-locksyringe) and a slip-on cap 252 intended for positioning on port 254 ofsyringe 250. More particularly, the anti-tampering apparatus 201 may beprovided to restrainably retain, or capture, cap 252. In oneapplication, the syringe 250 may be filled with a drug in a liquid formprior to cap 252 placement on port 254 and capture by anti-tamperingapparatus 201.

The anti-tampering apparatus 201 may comprise a frame member 210.Optionally, and as shown, frame member 210 may be at least partiallytransparent. The anti-tampering apparatus 201 may further include atleast one retention member(s) 220 connected to the frame member 210 anddisposed to capture cap 252. In addition, anti-tampering apparatus 201may include at least one pivot member(s) 230 disposed to provide anobstruction surface(s) thereupon to restrict recapping of syringe 250 bycap 252 after capture of cap 252 within anti-tampering apparatus 201. Inthe illustrated embodiment, a plurality of retention members 220 and aplurality of pivot members 230 may project inwardly from a sidewall 212of the frame 216.

The frame member 210, retention member(s) 220 may be integrally definedin a unitary anti-tampering apparatus embodiment. For example,anti-tampering apparatus 201 may be injection-molded from apolymer-based material. In some embodiments, the anti-tamperingapparatus may comprise a polypropylene material or a stifferpolyethylene or polystyrene material.

In the illustrated embodiment, the frame member 210 is configured as acap, with cylindrical sidewalls 212 and an end wall 213. In otherembodiments, the frame member 210 may assume other configurations.

FIG. 11 illustrates the syringe 250 prior to capping of port 254 by cap252, and prior to capture of cap 252 by anti-tampering apparatus 201.Such further capping and capture steps may be sequentially completed, asreflected by FIGS. 12, 13A and 13B. Further, such steps may be completedmanually and/or in an automated manner by relative linear advancement ofcap 252 and port 254 of syringe 250, and by relative linear advancementof capped syringe 250 and anti-tampering apparatus 201. In someapplications, such steps may be completed in a single-stroke, linearmovement of syringe 250. For example, cap 252 and anti-tamperingapparatus 201 may be held in aligned positions (see, e.g., FIG. 11) by afixture and syringe may be linearly advanced in a first stroke segmentto locate cap 252 on port 254. In turn, capped syringe 250 may belinearly advanced in a second stroke segment to capture the cap 252 ofthe capped syringe 250 within the anti-tampering apparatus 201.

As shown in FIG. 11, the frame member 210 may define an encompassed orinternal area 214 having a length L₆. Further, the frame member 210 maycomprise an opening 216 to the encompassed or internal area 214 forreceiving the cap 252 after positioning the cap 252 on the port 254 ofsyringe 250.

In turn, the retention member(s) 220 may define a capture region 217having a length L₅. In this regard, the retention member(s) 220 may beprovided so that, after placement of cap 252 on port 254 of syringe 250,as shown in FIG. 12, at least a portion of cap 252 may be forciblyadvanced past the retention member(s) 220 in a first direction andretainably captured within the capture region 217. In this regard, atleast a portion of retention member(s) 220 and/or frame 210 and/or cap252 may resiliently flex, or elastically deform, during cap capture.FIG. 13A illustrates cap 254 on syringe 250 entering the anti-tamperingapparatus 201, and FIG. 13B illustrates cap 252 captured withinanti-tampering apparatus 201.

After capture of at least a portion of cap 252 in capture region 217,syringe 250 and/or anti-tampering apparatus 201 may be moved relative tothe other, e.g., syringe 250 may be retracted in the second directionwhile anchoring anti-tampering apparatus 201, wherein captured cap 252may be removed from port 254 of syringe 250, as shown in FIG. 15. Inconjunction with removal of cap 252 rounded portion 252 a thereof mayengage and be restrainably retained within capture region 217 byretention member(s) 220. As may be appreciated, such cap removal may becompleted in conjunction with intended procedures in which the liquiddrug may be administered from syringe 250 to an intended patient afterremoval of cap 252.

As shown in FIG. 13A, the retention member(s) 220 may be of a barb-likeconfiguration, wherein the retention member(s) 220 includes a taperedsurface 221 and ledge surface 222. The retention member(s) 220 may bedisposed to restrainably engage flange 252 a of cap 252 at ledge surface222 when captured cap 252 is moved toward opening 216. The retentionmember(s) 220 may be located to restrict movement of the cap 252 in asecond direction opposite to the first direction. By way of example,retention member(s) 220 may define a minimum cross-dimension, or minimumdiameter of a circular opening, within encompassed area 214 that is lessthan a maximum cross-dimension, or diameter, of cap 252. In theillustrated embodiment, the maximum cross-dimension of cap 252 may bedefined by a periphery of rounded portion 252 a of cap 252 defining amaximum diameter thereto.

As shown by FIG. 6, the anti-tampering apparatus 201 may be provided sothat once cap 252 is captured in capture region 217 of anti-tamperingapparatus 201, and cap 252 is removed from port 254 of the syringe 250,the anti-tampering apparatus 201 may obstruct any attempt to recap theport 254 with the captured cap 252.

In this regard, and as noted above, anti-tampering apparatus 201 mayinclude pivot member(s) 230 for obstructing recapping of syringe 250 bycap 252 when captured in anti-tampering apparatus 201. To describe theoperation of pivot member(s) 230, reference is made to FIGS. 13A, 14 and15. As illustrated in FIG. 13A, pivot member(s) 230 may include a firstportion 232 and a second portion 234 extending in different directionsfrom a region of adjoinment to sidewall 212 of frame 210. Moreparticularly, the first portion 232 may extend in a direction towardsopening 216 and the second portion 234 may extend in a direction awayfrom the opening 216.

As shown in FIG. 13A, the pivot member(s) 230 may be in a first positionprior to and at the outset of insertion of cap 252 into theanti-tampering apparatus 201. Then, as shown in FIG. 14, upon forcedinsertion of cap 252 into anti-tampering apparatus 201 the pivotmember(s) may be disposed in a second position. More specifically, thesecond portion 234 may be pivot toward sidewall 212 and first portion232 may be pivot away from sidewall 212. The pivot motion of firstportion 232 may be limited by the presence of port 254 of syringe 250.In turn, and as shown in FIG. 15, upon removal of cap 252 from syringe250, second portion 252 may further pivot away from sidewall 212. Inturn, upon any attempt to recap syringe 250 with captured cap 252,second portion 252 of pivot member(s) 230 may engage the collar 254 b ofport 254 and thereby obstruct recapping.

In the embodiment shown in FIGS. 11-15, syringe 250 may comprise abarrel (e.g., having volumetric gradations, or indicia, thereupon) and aplunger disposed therein for selective dispensation of predeterminedamounts of a liquid drug (e.g., a predetermined unit dosage amount).Syringe 250 may be of a type having a port 254 adapted for forcible,slip-on placement of cap 252. In this regard, syringe 250 may be of atype having a luer-lock connection arrangement at port 254, as shown inFIG. 12. For example, port 254 may include a nozzle 254 a extendingthrough and beyond a surrounding collar 254 b. In turn, cap 252 mayinclude an annular (e.g., cylindrical) inner collar 252 b and an annular(e.g., cylindrical) outer collar 252 c extending from an end wall 252 d,wherein nozzle 254 a may be forcibly advanced in a slip-on fashion intoinner collar 252 b of cap 252, and outer collar 254 b of port 254 may belocated in an annular region defined between inner collar 254 b andouter collar 252 c of cap 252.

The above-described anti-tampering apparatus embodiments 1, 101 and 201,and their corresponding drug delivery devices and caps, syringe 50/cap52, oral dispenser 150/cap 152 and syringe 250/cap 252, respectively,may be provided as corresponding products and intended correspondinguse. By way of example, in certain embodiments, anti-tampering apparatus1 may be provided with indications that the anti-tampering apparatus 1is compatible for use with syringes and caps of a type correspondingwith syringe 50/cap 52. In other embodiments, anti-tampering apparatus101 and 201 may be provided in corresponding relation to and/or withindications of compatibility with oral dispenser 150/cap 152 and syringe250/cap 252. In either of the noted approaches, combinative products andassociated methodologies may be advantageously employed in variousembodiments of the present invention.

In the later regard, method embodiments may provide for handling of adrug delivery device (e.g., a syringe, oral dispenser or other drugdelivery device) having a port, and a corresponding cap positionable onthe port. In various embodiments, a method may include capturing a cap(e.g., 52, 152, 252) disposed on a port (e.g., 54, 154, 254) of a drugdelivery device (e.g., 50, 150, 250) within an anti-tampering apparatus(e.g., 1, 101, 201), removing the cap (e.g., 52, 152, 252) from the port(e.g., 54, 154, 254) of the drug delivery device (e.g., 50, 150, 250),wherein the anti-tampering apparatus (e.g., 1, 101, 201) maintainscapture of the cap (e.g., 52, 152, 252), and restricting repositioningof the cap (e.g., 52, 152, 252) onto the port (e.g., 54, 154, 254) ofthe drug delivery device (e.g., 50, 150, 250).

As may be appreciated, cap capture may be realized in various methodsembodiments via utilization of retention member(s) (e.g., 20, 120 and220) as described above. Further, restriction of repositioning of thecap onto the port of the corresponding drug delivery devices may berealized be the provision of obstruction surfaces (e.g., 18, 118 andsurfaces of pivot members 230), as described in conjunction with thevarious embodiments hereinabove.

The noted methodology may be readily integrated into overall processesfor handling of drug delivery devices. For example, drug deliverydevices such as syringe 1, oral dispenser 101 and/or syringe 201,together with their corresponding caps 52, 152 and 252, may be packagedat a first production and/or assembly facility. In this regard, the drugdelivery devices and associated caps may be packaged in the same ordifferent enclosures and sterilized at the production facility. Further,the anti-tampering apparatus may be packaged at the same or a relatedproduction and/or assembly facility. Packaging for the drug deliverydevices, corresponding caps and anti-tampering apparatus' may includemarkings or other indicia regarding compatibility for combinative use.In turn, the corresponding drug delivery devices and caps, and theanti-tampering apparatus, may be transported together or separately tousers at medical care locations. By way of primary example, suchproducts may be delivered to pharmacies located at hospitals and othermedical care facilities.

Once delivered, the drug delivery devices and caps, and theanti-tampering apparatus, may be unpackaged for use at such facilities.For example, after unpackaging, the drug delivery devices may be filledwith liquid medications corresponding with the type and nature of eachgiven drug delivery device. Moreover, such filling may be completed on apatient specific basis within pharmacies associated with each givenmedical care facility. Further, the filled drug delivery devices may becapped with their corresponding caps. Then the caps of the capped drugdelivery devices may be captured by the anti-tampering apparatus asdescribed herein. In some applications, filling of the drug deliverydevices, capping of the drug and cap capturing may be carried outmanually. In other applications, such steps may be completed inautomated fashion at medical care facilities.

In any case, after capture within anti-tampering apparatus, removal of acaptured cap from a given drug delivery device may be completed in amanual manner by medical personnel attendant to the administration of aliquid medication to a patient. For example, the anti-tamperingapparatus and drug delivery device may be anchored by different hands ofa user, wherein relative movement of the hands may cause the port of thedrug delivery device to retract out of the opening of the drug deliverydevice and disengage from the corresponding cap.

The foregoing description of the present invention has been presentedfor purposes of illustration and description. Furthermore, thedescription is not intended to limit the invention to the form disclosedherein. Consequently, variations and modifications commensurate with theabove teachings, and skill and knowledge of the relevant art, are withinthe scope of the present invention. The embodiments describedhereinabove are further intended to explain known modes of practicingthe invention and to enable others skilled in the art to utilize theinvention in such or other embodiments and with various modificationsrequired by the particular application(s) or use(s) of the presentinvention. It is intended that the appended claims be construed toinclude alternative embodiments to the extent permitted by the priorart.

What is claimed is:
 1. A method for handling a drug delivery devicecomprising: filling the drug delivery device with a predetermined amountof a liquid medication; positioning a cap on a port of said drugdelivery device after said filling step; and, capturing said capdisposed on said port of said drug delivery device within at least aportion of an anti-tampering apparatus, wherein said cap isnon-removable from said anti-tampering apparatus after said capturingstep.
 2. A method as recited in claim 1, further comprising: removingsaid cap from said port of said drug delivery device, wherein saidanti-tampering apparatus maintains capture of said cap; and, restrictingrepositioning of said cap onto said port of said drug delivery device.3. A method as recited in claim 2, wherein said restricting stepcomprises: providing an at least one obstructive surface on saidanti-tampering apparatus located to engage a surface of said drugdelivery device and thereby obstruct repositioning of the cap on saidport of said drug delivery device.
 4. A method as recited in claim 3,wherein said at least one obstruction surface is located in an initialposition prior to said capturing step, and wherein said at least oneobstruction surface is automatically located in an obstruction positiondifferent from said initial position after said removing step.
 5. Amethod as recited in claim 4, further comprising: first moving said atleast one obstruction surface from said initial position to anotherposition in response to said capturing step; and, second moving said atleast obstruction surface from said another position to said obstructionposition in response to said removing step.
 6. A method as recited inclaim 4, wherein said at least one obstruction surface is located on apivot member interconnected to a frame of said anti-tampering apparatus,and further comprising: pivoting said pivot member relative to saidframe to at least partially position said obstruction surface from saidinitial position to said obstruction position in response to saidcapturing step.
 7. A method as recited in claim 6, wherein at least aportion of at least one of said pivot member and/or said frame iselastically deformed after said capturing step and prior to saidremoving step, wherein said pivot member applies a spring force againstsaid drug delivery device after said capturing step and prior to saidremoving step, and wherein the method further comprises: advancing saidobstruction surface to said obstruction position in conjunction withsaid removing step in response to said spring force.
 8. A method asrecited in claim 3, wherein said at least one obstruction surface andsaid cap are located in a first relative position after said capturingstep and prior to said removing step, wherein said at least oneobstruction surface and said cap are positioned or positionable in asecond relative position after said removing step, and wherein saidobstruction surface restricts repositioning of said cap onto said portof said drug delivery device when said obstruction surface and said capare positioned in said second relative position.
 9. A method as recitedin claim 8, wherein said anti-tampering apparatus includes an openingand a capture region to receive and capture of said cap, respectively,and further comprising: moving said cap within said capture region in adirection away from opening after said removing step to locate said capand said obstruction surface in said second relative position.
 10. Amethod as recited in claim 7, wherein at least a portion of saidanti-tempering apparatus is elastically deformed to apply a spring forceagainst said drug delivery device after said capturing step and prior tosaid removing step, and further comprising: moving said obstructionsurface in conjunction with said removing step in response to saidspring force, wherein said obstruction surface and said cap areautomatically located in said second relative position.
 11. A method asrecited in claim 1, wherein said capturing step comprises: advancing atleast a portion of said cap forcibly past at least one retention memberprovided on said anti-tampering apparatus, wherein said cap isrestrainably disposed within a capture region of said anti-tamperingapparatus.
 12. A method as recited in claim 11, further comprising:flexing at least a portion of at least one of said cap and saidanti-tampering apparatus during said capturing step.
 13. A method asrecited in claim 1, further comprising: advancing linearly said port ofsaid drug delivery device to successively complete said positioning andcapturing steps.
 14. A method as recited in claim 13, wherein saidadvancing step is completed manually.
 15. A method as recited in claim13, wherein said advancing step is completed in an automated manner. 16.A method as recited in claim 1, further comprising: completing saidfilling step and said positioning step at a first location; and,removing said cap from said port of said drug delivery device at asecond location, remote from said first location, wherein saidanti-tampering apparatus maintains capture of said cap.
 17. A method asrecited in claim 16, further comprising: completing said capturing stepat said first location; and, labeling said drug delivery device at saidfirst location to provide an identification indication correspondingwith at least one of said liquid medication and a corresponding intendedrecipient of said liquid medication.
 18. A method as recited in claim16, further comprising: completing said capturing step at said secondlocation.
 19. A method as recited in claim 1, further comprising:packaging said drug delivery device and said cap at a first location.20. A method as recited in claim 19, further comprising: sterilizingsaid drug delivery device and said cap at said first location.
 21. Amethod as recited in claim 19, further comprising: unpackaging said drugdelivery device and said cap at a second location, remote from saidfirst location.
 22. A method as recited in claim 18, further comprising:completing said filling step, said positioning step, and said capturingstep at said second location.
 23. A method as recited in claim 22,further comprising: providing said anti-tampering apparatus to saidsecond location separate from said drug delivery device and said cap.